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Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive)

#1
Dear All, I work for a company that manufactures medical device class IIb implantable (93/42 directive). I want to understand in an easy manner, in case of a clinical assessment of the product after its placing on the market, how many patients I have to monitor? what should be the sample size? It is proportional to the units sold?
thanks for your help!!!
 
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QM_123

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#2
Dear Armando,

As I know it is determined through a statistical analysis. It is not my field but when we decided to contact a PMCF study, our consultant mentioned an analysis to determine study population number, I am not sure but as I remember it is called as power analysis.
 
#3
Dear QM_123,
you are right, but it is not easy to calculate it if you are not a statistician. I hoped to meet the requirements in a simpler way.....
thanks anyway !!!
 
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